Breast Implants for Reconstruction: a Closer Look

by Stephanie Donne

Of the tens of thousands of American women each year who undergo mastectomies, approximately 75 percent go on to have one or both breasts surgically reconstructed, according to breastcancer.org. Roughly half of these women opt for surgery that rebuilds the breast using their own body tissue. Most of the rest decide on artificial implants.

The National Women’s Health Network is extremely concerned about the safety of breast implants, and we believe that no implant should be approved without long-term data on safety and effectiveness. Yet despite a dearth of this data, breast implants are available in this country. Silicone gel-filled implants were first introduced in the 1960s and remain available through clinical trials for women undergoing surgical reconstruction after mastectomy. In 2000, the Food and Drug Administration (FDA) also approved saline breast implants for reconstructive and augmentative use.

Silicone gel implants have not been available outside clinical trials since 1992, when the FDA banned them because of long-term safety concerns. In 2004, the FDA rejected Inamed’s application to bring silicone gel implants back to the market, a decision NWHN supported.

Breast Implants Cause Known Health Problems

All women with silicone gel or saline implants can experience post-surgical complications, including pain, capsular contracture (hardening of the tissue that forms around the implant), infection, inflammation or irritation, breasts that are not the same size or shape, and breasts that look wrinkled.

These complications may require additional surgeries to remove or replace the implants. A study of Inamed’s saline breast implants found that after three years, 21 percent of augmentation patients and 40 percent of reconstruction patients required additional surgeries. Inamed’s study of its silicone gel implants showed that 20 percent of breast augmentation patients and 46 percent of breast reconstruction patients required additional surgeries within three years.

There are unanswered questions about systemic and long-term health problems associated with implants. A study by FDA scientists found a significant link between silicone gel implants and fibromyalgia, a disorder that causes pain and fatigue in the muscles, tendons and ligaments. A National Cancer Institute study found that women with silicone gel implants had increased risk of cancers of the brain, respiratory tract, cervix and vulva. It is not known if reconstruction patients are more likely to experience these problems than augmentation patients.

Silicone Gel Implants May Cause Unknown Health Problems

We still do not know enough about the long-term disease risk of women with implants. Women with silicone implants have reported a variety of autoimmune diseases, including scleroderma, rheumatoid arthritis and lupus. These diseases are rare and take many years to develop and be diagnosed, and all studies on silicone implants and autoimmune diseases have been short-term and have included small numbers of women. As a result, the connection between implants and long-term risk of these diseases remains unknown.

Researchers have suggested that if a woman is already more likely to develop an autoimmune disease for other reasons, her exposure to toxins in silicone gel may trigger the development of that disease.

Breast Implants and Mammography

All breast implants interfere with accurate mammography readings and can be ruptured by the compression of breasts during mammograms. Other potential adverse events, as identified in a recent study by FDA scientists, include delayed breast cancer detection, pain and soreness during and after the mammogram and, in the event of capsular contracture, inability to perform a mammogram. There are ways to minimize implants’ interference with accurate mammography, but approximately 30 percent of the breast tissue will remain obscured in the image.

Breast Implants Break

Some implants break within the first few months of being implanted, and some last more than 15 years. But no implant lasts forever. At some point, all women with breast implants will require additional surgery to replace or remove their implants.

When saline implants rupture, the saline typically leaks out quickly and the implant deflates. Women are usually aware that their implant has ruptured because the breast changes in size or shape. When the saline leaks out of the implant, it is absorbed into the body. This in itself is usually harmless, but bacteria or fungus from inside the implant may also leak into the body.

Silicone gel implants are filled with a thick cohesive gel. When they rupture, women sometimes notice changes in the breast’s size or shape, along with pain, swelling, numbness or tingling. But most silicone ruptures are known as silent ruptures and occur without any symptoms. The only way to accurately detect a silicone rupture is with MRI.

After a silicone rupture, silicone gel can remain within the capsule of scar tissue that forms around the implant, or it can leak outside the scar tissue and travel to distant points throughout the body. The long-term effects of silicone gel on the health of women have not been adequately researched. It is not known whether these effects may be different in women who have had cancer.

Adapted from a NWHN fact sheet. For more information on breast cancer or reconstruction options, contact the NWHN clearinghouse, 202.628.7814.

Stephanie Donne is NWHN’s program director.